3D printed medical devices are on the rise as printing them becomes more accessible to many hospitals. Some hospitals have begun to print the devices patients need in-house, using their own printer to render custom designs to fit the needs of their patients. As this new medical technology gains traction, it raises the question of who is responsible when a patient is injured by a custom-printed device.
In traditionally manufactured medical devices, the manufacturer must put all designs and devices through rigorous quality control tests. The FDA oversees all safe manufacturing processes and enforces quality standards for the medical devices they produce. When a doctor designs and prints a 3D printed device, they take on the role of the manufacturer, but legally, they are still considered a consumer, and not a supplier of medical devices. In product liability cases, it can be difficult to place blame on a doctor who created a faulty device.
Under current laws, patients are relegated to making negligence claims to recover damages after being injured by a 3D printed device. In a negligence claim, victims will need to prove that their doctor breached their duty of care to the patient, the device directly caused the injury, and that they sustained injuries and expenses due to the device. Since the technology is so new, finding expert witnesses to help the victim’s claim can be a challenge.
If the device was recommended or the use of a 3D printed device was supervised by hospital staff or a doctor, it may be possible to file a medical malpractice claim. To file a medical malpractice claim, you will need to demonstrate that the device was used incorrectly, there was improper training in regard to the device’s use or creation, or that there was a failure to provide informed consent about the procedure, including the potential risks. If you are able to show that your doctor did not demonstrate reasonable skill and care, you may be able to recover damages.
If you’ve been injured by a 3D printed medical device, you should contact our Albuquerque personal injury attorney. Michael J. Doyle, Attorney At Law has more than a decade of experience helping injured victims with a variety of personal injury claims, including medical malpractice claims. We offer the one-on-one legal service you deserve. Contact Michael J. Doyle, Attorney At Law today to request a free consultation.